FDA Enforcement
Class II
Ongoing
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Recall: Z-0499-2025
·
Reported November 27, 2024
Enforcement
- Recall Number
- Z-0499-2025
- Event ID
- 95582
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2024
- Initiation Date
- October 14, 2024
- Classification Date
- November 21, 2024
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
Description
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Reason
Devices from the affected device lots have labels that state the incorrect expiration dates.
Code Info
UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Distribution
International Distribution to: Korea only
Quantity
10 units